0677 SS Part A for 2017 Extension

Food and Drug Administration (FDA):
Focus Groups About Drug Products
OMB Control Number 0910-0677
Supporting Statement
Part A

A. Justification
1. Circumstances Making the Collection of Information Necessary
Under the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 393(d)(2)(D)), the Commissioner of
Food and Drugs is authorized to conduct educational and public information programs. To
support these efforts, the Food and Drug Administration (FDA or we) is requesting approval for
information collection through the use of focus groups for studies involving drug products that
are regulated by the agency. The information collection will employ statistical methods, as
described in our Supporting Statement Part B, to explore concepts of interest and assist in the
development of quantitative study proposals, complementing other important research efforts in
the agency. This information may also be used to help develop communication messages and
campaigns. Focus groups play an important role in gathering information because they allow for
an in-depth understanding of individuals’ attitudes, beliefs, motivations, and feelings. Focus
group research serves the narrowly defined need for direct and informal public opinion on a
specific topic.
2. Purpose and Use of the Information Collection
FDA will use routine contacts with customers, review of subject materials and other qualitative
information collection activities to identify areas of interest and concern to customers. FDA will
use in-house statistical staff and outside contractors to develop focus group plans. According to
OMB guidelines for generic clearances for focus groups, we will establish an independent review
process to assure the development and implementation of high quality focus groups. Specifically
we hope to utilize focus groups: to obtain information useful for developing variables and
measures for quantitative studies; to better understand people’s attitudes and emotions in
response to topics and concepts; and to further explore findings obtained from quantitative
studies.
3. Use of Improved Information Technology and Burden Reduction
Focus group studies are directed group discussions that enable skilled observers to infer the
underlying views and assumptions of the group members that are expressed in the discussion.
To facilitate interpretation, discussions are recorded and videotaped (when appropriate) so that
both a visual record and written transcript of the discussion are available for review. Focus
groups are generally held in locations that participants travel to by car or short-range public
transportation. When a specialized population of participants is necessary, such as physicians
with expertise in a particular specialty, focus groups may be held at scientific or academic
meetings. Some geographic diversity may be built in where such diversity is deemed appropriate

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by conducting focus groups in different regions across the 48 contiguous United States.
Sometimes, however, when there is a particular need for rapidly gathering information from
people who are located across the United States, focus groups may be held by telephone and may
use Web technology to decrease burden and increase efficiency.
4. Efforts to Identify Duplication and Use of Similar Information
We are unaware of duplicative information collection.
5. Impact on Small Businesses or other Small Entities
Respondents to the information collection are private individuals.
6. Consequences of Collecting the Information Less Frequently
Usually a set or series of focus groups is collected only once to provide information or explore a
particular topic of interest. Because focus groups are considered a first step to explore concepts
of interest and develop quantitative research proposals, failing to collect the information will
cause delays in the development of programmatic concepts and impede the development of
quantitative research, which will in turn inhibit substantive policy formation. In addition, with
respect to developing communications, in the absence of information collected through
qualitative formative testing, the messages developed are much less likely to be effective and
hence run the risk of being an inefficient use of government resources.
7. Special Circumstances Relating to the Guidelines of 5 CFR 1320.5
There are no special circumstances for the collection of information.
8. Comments in Response to the Federal Register Notice and Efforts to Consult Outside the
Agency
In accordance with 5 CFR 1320.8(d) we published a 60-day notice in the Federal Register on
November 7, 2016 (81 FR 78161). We received no comments that pertained to the information
collection analysis.
9. Explanation of any Payment or Gift to Respondents
It is standard practice in commercial market research to offer recruited respondents some form of
remuneration for the time they spend engaged in the focus group. As has been approved by
OMB in the past, focus group participants may be offered an incentive (usually $50 to $75,
consistent with general Federal government practice). Incentives for Web-based or telephone
focus groups will generally be offered at a lower rate. Incentives for difficult-to-recruit
populations may be offered at a higher rate such as $150 (or potentially more) for certain medical
specialists. FDA will provide a rationale in the justification memo for any studies that propose
to offer non-standard rates.

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Circumstances, however, do not always require that remuneration be given; many audiences
including the public, patients, survivors, and some health professionals often participate gratis
because of their interest or involvement in the topic, or as a professional courtesy.
10. Assurance of Confidentiality Provided to Respondents
While anonymity of respondents generally cannot be assured unless there is a statutory
requirement associated with the information collection, the information collected from
respondents will be secured by using an independent contractor to collect the information, by
enacting procedures to prevent unauthorized access to respondent data, and by preventing the
public disclosure of the responses of individual participants. FDA will never be given respondent
surnames and will keep all recordings under lock and key. Contractor reports do not associate
personal identifiers with any statements excerpted for illustrative purposes.
11. Justification for Sensitive Questions
For the vast majority of focus groups, no questions will be asked that are of a personal or
sensitive nature. Some drug products regulated by FDA are for conditions that are considered
personal and potentially embarrassing. Therefore, there may be instances in which a particular
topic of interest touches upon issues that could be considered sensitive. In these cases, care will
be taken to ensure that any questions are absolutely necessary to the purpose of the information
collection, are asked in a sensitive and respectful way, and that participants’ right to refuse
response is protected.
12. Estimates of Annualized Burden Hours and Costs
FDA staff were asked for the number of studies and size of the focus groups about drug products
that they plan to conduct next year. The following burden estimates are based on FDA’s
projected focus group usage for the next year.
12a. Estimated Annual Reporting Burden
FDA’s Center for Drug Evaluation and Research (CDER), the Office of the
Commissioner, and any other agency components conducting focus groups about regulated drug
products will utilize the focus group generic approval, as appropriate, on a variety of subjects
related to consumer, patient, or healthcare professional perceptions and use of drug products and
related materials, including but not limited to, direct-to-consumer prescription drug promotion,
physician and other healthcare professional prescription drug promotion, physician labeling of
prescription drugs, Medication Guides, over-the-counter drug labeling, emerging risk
communications, patient labeling, on-line sales of medical products, and consumer and
professional education.
FDA plans to conduct approximately 20 focus group studies using approximately 160
focus groups on a variety of topics related to regulated drug products. Each study will include a
variable number of groups, potentially representing different geographic and educational strata.
Each focus group includes on average 9 participants, and lasts an average of 1.75 hours. The

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estimated total number of respondents is 1,440. Therefore, the total annual estimated burden
imposed by this collection of information is approximately 2,520 hours.
Table 1 – Estimated Annual Reporting Burden1
Activity

Number of
respondents

Focus Group Study

1,440

1

Number of
responses per
respondent
1

Total annual
responses

Average burden
per response

Total
Hours

1,440

1.75

2,520

There are no capital or operating or maintenance costs associated with the information collection.

12b. Estimated Annual Cost Burden
There are no annualized costs to respondents for the burden hours for this collections of
information.
13. Estimates of Other Total Annual Cost Burden to Respondents and Recordkeepers
There are no capital or operating and maintenance costs associated with the information
collection.
14. Annualized Cost to the Federal Government
The agency incurs costs to set up the focus groups, including hiring a contractor to provide a
facilitator/moderator, rent meeting space, travel to conduct the groups, and provide respondents
with payment of a de minimis cost in the form of a token stipend. For these expenses, FDA
spends approximately $200,000 annually.
15. Explanation for Program Changes or Adjustments
There are no program changes or adjustments to this information collection.
16. Plans for Tabulation and Publication and Project Time Schedule
Although the agency has no plans to publish its findings, we may receive requests to release the
information (e.g., congressional inquiry, Freedom of Information Act requests). FDA will
disseminate focus group findings only when appropriate, strictly following our “Guidelines for
Ensuring the Quality of Information Disseminated to the Public,” and will include specific
discussion of the limitations of focus group results with regard to being non-quantitative.
17. Reason(s) Display of OMB Expiration Date Is Inappropriate
Display of the OMB expiration date is appropriate.
18. Exceptions to Certification for Paperwork Reduction Act Submissions
There are no exceptions to the certification.